An interventional study of Grade 2-5 CI Therapy + Sensory Components in CVA (Cerebrovascular Accident), Stroke and Upper Extremity Paresis, sponsored by University of Alabama at Birmingham. Recruiting at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Treatment
Constraint-Induced Movement Therapy or CI Therapy is a form of treatment that systematically employs the application of selected behavioral techniques delivered in intensive treatment over consecutive day with the following strategies utilized: behavioral strategies are implemented to improve the use of the more- affected limb in life situation called a Transfer Package (TP), motor training using a technique called shaping to make progress in successive approximations, repetitive, task oriented training, and strategies to encourage or constrain participants to use the more-affected extremity including restraint of the less-affected arm in the upper extremity (UE) protocol. Numerous studies examining the application of CI therapy with UE rehabilitation after stroke have demonstrated strong evidence for improving the amount of use and the quality of the more-affected UE functional use in the participant's daily life situation.
CI Therapy studies with adults, to date, have explored intensive treatment for participants with a range from mild-to-severe motor impairment following stroke with noted motor deficits and limited use of the more-affected arm and hand in everyday activities. Each CI Therapy protocol was designed for the level of impairment demonstrated by participants recruited for the study. However, often following stroke, patients not only have motor deficits but somatosensory impairments as well. The somatosensory issues have not, as yet, been systematically measured and trained in CI Therapy protocols with adults and represent an understudied area of stroke recovery. We hypothesize that participants with mild-to-severe motor impairment and UE functional use deficits can benefit from CI therapy protocols that include somatosensory measurement and training components substituted for portions of motor training without loss in outcome measure gains. Further, we hypothesize that adults can improve somatosensory outcomes as a result of a combined CI therapy plus somatosensory component protocol.
The purpose of this study is to systematically examine the feasibility of adding somatosensory components to CI Therapy protocols for patients having mild-to-severe impairment to improve more-affected UE use, motor ability, and sensory perception in the chronic phase of stroke recovery. Treatment will follow previous timeframes of CI Therapy protocols of 2 weeks of intervention for mild-to-moderate UE impairment and 3 weeks for severe UE impairment. The Motor Activity Log (MAL) and Grade 4/5 Motor Activity Log (G4/5 MAL) are used to measure use of the more affected UE by participants with mild-to-moderate impairment and severe impairment, respectively. Motor capacity is measured by the Wolf Motor Function Test (WMFT) for those with mild-to-moderate impairment and the Grade 5 - Graded Wolf Motor Function Test (G5-GWMFT) for those with severe UE impairment. Participants: 15 post-stroke participants in the chronic phase of recovery (at least 6 months post-stroke) will be enrolled. Participants in this study must at least meet the minimal motor criteria for severely impaired participants. Thus, prior to treatment, participants must be able to demonstrate movement more-affected UE including the ability to move the shoulder ≥ 30 toward flexion or abduction, initiate movement at the elbow for flexion and extension, and initiate movement at the wrist, fingers, or thumb. Outcome Measures: Aim 1 will be assessed using the MAL (Arm use) for mild-to-moderately impaired participants or the G4/5 MAL (Arm use) for severely impaired participants, WMFT (UE motor capacity) for mild-to-moderately impaired and G5-GWMFT (UE motor capacity) for severely impaired participants, SIS (Stroke Impact Scale - Quality of Life), Zung Depression Scale (ZDS-Mood), and Canadian Occupational Performance Measure (COPM - Functional activity preference, ability and satisfaction). All measures will be administered immediately pre-treatment and at post-treatment. The MAL or G4/5 MAL, SIS, COPM, and ZDS will also be administered at 3 months post-intervention by telephone. Aim 2 will be assessed by Revised Nottingham Sensory Assessment (rNSA-Sensation) and Semmes \& Weinstein Monofilament Test (SWMT- Sensation). These measures will be performed immediately pre-treatment and at post-treatment. Intervention: Participants will receive CI therapy plus somatosensory training components for the more-affected upper extremity for 2-3 weeks (depending on the level of UE impairment severity) for 3.5 hours per weekday. Specific CI therapy strategies will be delivered as is described with the addition of somatosensory components for the more-affected arm and hand. CI therapy strategies include: 1.) supervised movement training for 3.5 hours 5 weekdays x 2-3 weeks; 2.) participants will wear a restraint mitt on the less-affected hand for the majority of their waking hours for the 2-3 weeks; 3.) a transfer package will be used to help the participant transfer their gains from the laboratory to the life situation. Sensory components may be used to increase sensory input to the brain and increase the attention of each participant to the more-affected UE. The sensory components may include 1.) sensory stimulation to the more-affected UE (e.g.; brushing the UE with soft bristle brush, vibration to the finger tips, massage to the UE, etc); 2.) sensory training tasks that require each participant to respond to what is felt through the UE (e.g.; object identification, temperature discrimination, material identification, etc.)
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 15 is below the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants will receive CI Therapy + Sensory Components administered over the specific time frame of 2-3 weeks.
Behavioral: Grade 2-5 CI Therapy + Sensory Components
All participants will receive CI Therapy + Sensory Components over a 2-3 weeks time frame. The treatment intervention will apply all CI Therapy treatment components to include: 1) a behavioral set of techniques called the Transfer Package (TP) to promote carry-over of skills that were gained in the laboratory into the participant's life situation, 2) the use of motor training called shaping to make progress in small approximations 3) the use by the participant of a mitt on the less-affected hand to encourage use of the more-affected hand and 4) home skills and home work will be provided each day for at least 30 minutes. Sensory component training strategies will be added to stimulate sensory input through the more-affected arm an dhand as well as to train sensory discrimination skills.
Motor Activity Log
The Motor Activity Log is a semi-structured interview that assesses the amount of use and the quality of use of the more-affected UE in 30 activities of daily living. This test is used to determine the change how much and how well the participant uses the more-affected arm and hand outside of the laboratory setting and in the life situation. It is administered before and after treatment. The score is derived from two scales that are each 0-5 and reported as a mean for the Amount of Use (AOU) and mean for the Quality of Use (QOM).
Time frame: At post treatment after 2 weeks of intervention for participants with mild-moderate UE impairment
Motor Activity Log
The Motor Activity Log is a semi-structured interview that assesses the amount of use and the quality of use of the more-affected UE in 30 activities of daily living. This test is used to determine the change how much and how well the participant uses the more-affected arm and hand outside of the laboratory setting and in the life situation. It is administered before and after treatment. The score is derived from two scales that are each 0-5 and reported as a mean for the Amount of Use (AOU) and mean for the Quality of Use (QOM).
Time frame: At 3 month follow up after the end of treatment
G4/5 Motor Activity Log
The G4/5 Motor Activity Log is a semi-structured interview that assesses the amount of use and the quality of use of the more-affected UE in 30 activities of daily living. This test is used to determine the change how much and how well the participant uses the more-affected arm and hand outside of the laboratory setting and in the life situation. It is administered before and after treatment. The score is derived from two scales that are each 0-5 and reported as a mean for the Amount of Use (AOU) and mean for the Quality of Use (QOM).
Time frame: At post treatment after 3 weeks of intervention for participants with severe UE impairment
G4/5 Motor Activity Log (G4/5 MAL)
The G4/5 Motor Activity Log is a semi-structured interview that assesses the amount of use and the quality of use of the more-affected UE in 30 activities of daily living. This test is used to determine the change how much and how well the participant uses the more-affected arm and hand outside of the laboratory setting and in the life situation. It is administered before and after treatment. The score is derived from two scales that are each 0-5 and reported as a mean for the Amount of Use (AOU) and mean for the Quality of Use (QOM).
Time frame: At 3 month follow up after the end of treatment
Wolf Motor Function Test(WMFT)
The WMFT is a standardized performance capacity test that measures the motor ability of the upper extremities of a participant. The performance time is measured using a stopwatch and a functional ability (quality) score is provided for each item tested. This test is administered before treatment and after treatment. The quality of movement is rated by the therapist on a scale from 0-5 with 0 representing the participant's inability to perform the task, and 5 representing normal movement or as good as before the stroke, such that a higher functional ability score is better. A lower performance time represents a better performance.
Time frame: At post treatment after the 2 weeks of intervention for mild to moderately impaired participants
Grade 5 Graded Wolf Motor Function Test (G5 GWMFT)
The G5 Graded WMFT is a standardized motor performance test that measures the motor ability of the upper extremities of a participant. The performance time is measured using a stopwatch and the functional ability (quality) score is provided for each item tested. It is administered before treatment and after treatment. The quality of movement is rated by the therapist on a scale from 0-7 with 0 representing the participant's inability to perform the task, and 7 representing normal movement or as good as before the stroke, such that a higher functional ability score is better. A lower performance time represents a better performance.
Time frame: At post treatment after the 3 weeks of intervention for severely impaired participants
Canadian Occupational Performance Measure (COPM)
The COPM is a semi-structured interview in which the participant is asked to rate their desired occupational performance areas in activities of daily living and instrumental activities of daily living. The COPM is used to show changes in the performance and satisfaction in desired areas of occupational performance. There are three scales used in the COPM administration one for importance, performance, and satisfaction. The scales range from 1-10 with the higher score indicating an improvement in the score.
Time frame: At post treatment after the 2-3 weeks of intervention, depending on the severity of the impairment.
Canadian Occupational Performance Measure (COPM)
The COPM is a semi-structured interview in which the participant is asked to rate their desired occupational performance areas in activities of daily living and instrumental activities of daily living. The COPM is used to show changes in the performance and satisfaction in desired areas of occupational performance. There are three scales used in the COPM administration one for importance, performance, and satisfaction. The scales range from 1-10 with the higher score indicating an improvement in the score.
Time frame: At 3 month follow up after the end of treatment
Zung Depression Scale (ZDS)
The ZDS is a 20-item self-report questionnaire that measures symptoms of depression. A total score is calculated by summing the individual items. The range of the scores is 20-80. Higher scores indicate more symptoms with a score of 70 or higher as severe depression. Administered before treatment, after treatment, and in followup at 3 months out from the treatment to detect changes in mood.
Time frame: At post treatment after 2-3 weeks of treatment, depending on the severity of the impairment
Zung Depression Scale (ZDS)
The ZDS is a 20-item self-report questionnaire that measures symptoms of depression. A total score is calculated by summing the individual items. The range of the scores is 20-80. Higher scores indicate more symptoms with a score of 70 or higher as severe. on. A total score is calculated by summing the individual items. The range of the scores is 20-80. Higher scores indicate more symptoms with a score of 70 or higher as severe depression. Administered before treatment, after treatment, and in follow-up at 3 months out from the treatment to detect changes in mood.
Time frame: At 3 month followup after the end of treatment.
Stroke Impact Scale (SIS)
The SIS is a self-report measure of 8 domains of quality of life and disability following stroke. The scoring can range from 1-100 with a higher score indicating a better quality of life and less disability. The SIS is administered in this study at pre-treatment, post-treatment and 3 month follow-up to detect changes in quality of life as a result of the treatment.
Time frame: At post-treatment following the 2-3 weeks of treatment, depending on severity of the impairment.
Stroke Impact Scale (SIS)
The SIS is a self-report measure of 8 domains of quality of life and disability following stroke. The scoring can range from 1-100 with a higher score indicating a better quality of life and less disability. The SIS is administered in this study at pre-treatment, post-treatment and 3 month follow-up to detect changes in quality of life as a result of the treatment.
Time frame: At 3 months follow-up after the end of treatment.
Revised Nottingham Sensory Assessment (rNSA)
The rNSA measures somatosensory impairments following stroke. The scores range from 0-2 with 0 representing absent sensation and 2 representing normal sensation while proprioception is scored as 0-3 with 0 representing absent and 3 representing joint position sense \< 10 degrees. Only the upper extremity portion will be tested and his test will be used to detect changes in sensation in the upper extremity as a result of treatment.
Time frame: At post-treatment after 2-3 weeks of treatment, depending in the severity of the impairment
Semmes-Weinstein Monofilament Test (SWMT)
The SWMT measures touch pressure with monofilaments of different diameters. The smaller the diameter of the monofilament, the more difficult to detect.
Time frame: At post-treatment after the 2-3 weeks of intervention, depending on the level of impairment
Participant Opinion Survey (PO Survey)
The PO Survey is a self-report measure that measures the participant's perspective and feelings about treatment components and use of the more-affected arm and hand. It is administered before treatment, half way through treatment, and at the end of treatment.
Time frame: At post-treatment after the 2-3 weeks of intervention, depending on the level of impairment
Plan to share: No
Started Mar 2023 (actual). Primary completion is estimated for Mar 2027, 48 months after the start.
Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's planned 48 months is above that.
Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.
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